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Haplo T-Cell Depleted Transplantation in High-Risk Sickle Cell Disease

Study acronym: HaploSCD
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 8, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2025 to Dec 2026
    v28
  2. Primary completion date: Dec 2023 to Dec 2024v27
  3. Re-verified, no change to tracked fieldsv26
  4. Primary completion date: Dec 2022 to Dec 2023v25
  5. Primary completion date: Jun 2022 to Dec 2022v24
Show 22 earlier versionsHide 22 earlier versions
  1. Re-verified, no change to tracked fieldsv23
  2. Primary completion date: Jun 2020 to Jun 2022v22 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 20 to confirmed 21
    • Study sites: 7 to 6
    • Study completion date: Dec 2022 to Dec 2025
    • Collaborators revised (8)
  3. Collaborators revised (8)v21
  4. Re-verified, no change to tracked fieldsv20
  5. Secondary endpoints: details revised at 1 of 3 entriesv19
  6. Primary completion date: Jun 2019 to Jun 2020
    • Study completion date: Dec 2019 to Dec 2022
    • Secondary endpoints: details revised at 1 of 3 entries
    v18
  7. Primary completion date: Dec 2018 to Jun 2019
    • Study completion date: Apr 2019 to Dec 2019
    v17
  8. Primary completion date: Apr 2018 to Dec 2018v16
  9. Site details revised at 2 of 7 sitesv15
  10. Primary completion date: Apr 2017 to Apr 2018
    • Study completion date: Apr 2018 to Apr 2019
    • Collaborators: 9 to 8
    v14
  11. Enrollment target: 35 to 20v13
  12. Site details revised at 2 of 7 sitesv12
  13. Eligibility criteria shortened, about 86 words
    • Site details revised at 1 of 7 sites
    v11
  14. Study sites: 5 to 7
    • Eligibility criteria shortened, about 183 words
    • Collaborators: 7 to 9
    v10
  15. Primary completion date: Apr 2016 to Apr 2017
    • Study completion date: Apr 2017 to Apr 2018
    v9
  16. Eligibility criteria shortened, about 15 words
    • Collaborators revised (7)
    v8
  17. Eligibility criteria shortened, about 13 words
    • Site contacts updated at 1 of 5 sites
    • Collaborators revised (7)
    v7
  18. Primary completion date: Jan 2016 to Apr 2016
    • Study completion date: Jan 2017 to Apr 2017
    • Collaborators: 9 to 7
    v6
  19. Study sites: 4 to 5
    • Eligibility criteria shortened, about 14 words
    • Study description revised
    • Collaborators: 8 to 9
    v5
  20. Interventions: CD34 selected T-cell depleted allogeneic stem cell transplantation (Drug) to CD34 selected T-cell depleted allogeneic SCT (Drug)
    • Study sites revised (4)
    • Collaborators: 9 to 8
    • Study arms: 0 to 1
    v4
  21. Eligibility criteria expanded, about 11 words
    • Study description revised
    v3
  22. Trial status: Not Yet Recruiting to Recruiting
    • Interventions: allogeneic stem cell transplantation (Procedure) to CD34 selected T-cell depleted allogeneic stem cell transplantation (Drug)
    • Site details revised at 4 of 4 sites
    • Collaborators: 8 to 9
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is being done to determine the safety and outcome (long-term control) of a high-dose chemotherapy regimen followed by an infusion of CD34 selected (immune cells) stem cells from a partially matched adult family member donor, called haploidentical stem cell transplantation, in high-risk sickle cell disease patients. Funding Source - FDA OOPD
Trial Details
NCT Number NCT01461837
Lead Sponsor New York Medical College
Collaborators: UCSF Benioff Children's Hospital Oakland, Medical College of Wisconsin, Washington University School of Medicine, Tufts Medical Center, University of California, San Francisco, University of California, Los Angeles, Miltenyi Biomedicine GmbH, Ann & Robert H Lurie Children's Hospital of Chicago
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov